Catalog Number

P12L55

Brand Name

Elation™

Version/Model Number

00884450198032

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KTI

Product Code Name

BRONCHOSCOPE ACCESSORY

Public Device Record Key

e9450c3a-f3fa-417b-ac8c-d54da1a7fdbc

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

January 27, 2017

Package DI Number

10884450198039

Quantity per Package

5

Contains DI Package

00884450198032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-